A Prospective Randomized Trial Comparing Single Plastic Stent Versus Multiple Plastic Stents in Inoperable Malignant Distal Bile Duct Obstruction.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 4
- 主要终点
- Clinical success rate
研究概览
简要总结
Endoscopic retrograde cholangiopancreatography (ERCP) with biliary stent placement is crucial for palliative treatment in patients with malignant bile duct obstruction who cannot perform surgery due to advanced diseases or associated comorbidities. Stent patency is challenge in ERCP. Self expanding metallic stents (SEMS) have a longer duration of patency and fewer of recurrence occlusion of stent when compared with plastic stent (PS). However, the cost of MS is more expensive than PS about 4 times. Therefore, many patients cannot afford the MS due to their economic status. Data regarding the efficacy and safety of multiple PS compared with single PS for the palliative treatment in unresectable malignant distal bile duct obstruction are limited.
详细描述
The aim of the current study is to compare the cumulative stent patency of multiple PS and single plastic stent and the clinical success rate as a primary objective, investigate the technical success rate, procedure time incident of overall adverse events including stent dysfunction and overall procedure related mortality as secondary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In-operable distal malignant bile duct obstruction Age>18
排除标准
- •Pregnancy ECOG 3-4 Can not correct coagulopathy Contraindicate for ERCP
结局指标
主要结局
Clinical success rate
时间窗: Four weeks after randomization
Proportion of patients with total bilirubin level declining \> 50 % of the initial value
Cumulative stent patency
时间窗: From the date of randomization though the study completion, assessed up to 1 year.
Proportion of patients with documented stent dysfunction
次要结局
- Technical success rate(From the date of randomization until the last stent deploy, assessed up to 1 day.)
- Overall adverse events(From the date of randomization until the date of documented adverse events, assessed up to 1 month.)
- Overall patient survival(From the date of randomization until the date of death from any cause, assessed up to 12 months.)
- Procedure relate death(From the date of randomization until the date of death from procedure within 7 days)
研究者
Nisa Netinatsunton
Principal Investigator
Prince of Songkla University